NCT05115162

Brief Summary

The aim of this study was to examine the effects of a 6-week hybrid telerehabilitation exercise program on sleep quality, depression and quality of life of university students with physical inactivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

November 1, 2021

Last Update Submit

November 1, 2021

Conditions

Keywords

Hybrid TelerehabilitationSleep QualityDepressionPhysical InactivityExercise

Outcome Measures

Primary Outcomes (2)

  • Pittsburgh Sleep Quality Index (PSQI):

    Measurement of the sleep quality

    At the baseline

  • Pittsburgh Sleep Quality Index

    Measurement of the sleep quality

    At the end of the 6th week

Secondary Outcomes (7)

  • Beck Depression Inventory

    At the baseline

  • Beck Depression Inventory

    At the end of the 6th week

  • Short Form-12

    At the baseline

  • Short Form-12

    At the end of the 6th week

  • International Physical Activity Questionnaire-Short Form

    At the baseline

  • +2 more secondary outcomes

Study Arms (2)

elerehablitation home exercise group

EXPERIMENTAL

Telerehabilitation home exercise group received indoor walking and general exercise program for 6 weeks. Indoor walking was performed 3 days a week, for 30 minutes. General exercise program was consisted of flexibility, strengthening the shoulder and trunk muscles, bridge exercises, lying on the back, cycling and squatting exercises. All of the general exercises were repeated 3 days a week, 2 sets and each set with 10 repetitions. Two synchronized exercise education sessions were performed with the exercise group. In the first of these sessions, the content of the exercise program was explained. In the second, it was checked whether the exercises were done correctly. After synchronous education sessions, an asynchronous home exercise program, consisting walking and general exercise program continued for 6 weeks.

Other: Exercise

Control Group

NO INTERVENTION

This group did not participate in any exercise program for 6 weeks.

Interventions

The exercises consist of flexibility, strengthening exercises for the trunk and extremities, and walking indoors.The walking program was applied for at least 30 minutes. Eight different exercises were given for the trunk and extremities and these exercises were applied 3 times a week, 2 sets, each set with 10 repetitions.

elerehablitation home exercise group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \>18 years old
  • Pittsburg Sleep Quality Index total score \>5 points
  • No history of orthopedic, neurological, or cardiovascular disease
  • Physical activity level \< 600 MET-min-week according to International Physical Activity Questionnaire-Short From.
  • Cooperative
  • Not exposed to any telerehabilitation application

You may not qualify if:

  • Having cancer, diabetes mellitus, pregnancy, infection, rheumatic pain
  • Less than 85% attendance to the program
  • Participating in any other physical activity program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivitySleep Initiation and Maintenance DisordersDepressionSedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 10, 2021

Study Start

December 1, 2020

Primary Completion

January 17, 2021

Study Completion

April 30, 2021

Last Updated

November 10, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations